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Brief Influenza Vaccine Education to Pregnant Women

This study is not yet open for participant recruitment.
Verified January 2013 by The University of Hong Kong
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01772901
First received: January 17, 2013
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.


Condition Intervention
Influenza
Infectious Disease
Pregnancy
 Other: Influenza Vaccine Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • The proportion of influenza vaccination [ Time Frame: 2 weeks postpartum ] [ Designated as safety issue: No ]
    The proportion of influenza vaccination in the control and intervention groups


Secondary Outcome Measures:
  • The influenza and influenza vaccine knowledge of participants [ Time Frame: 2 weeks postpartum ] [ Designated as safety issue: No ]
    The influenza and influenza vaccine knowledge of participants in the control and intervention groups after receiving the intervention.


Estimated Enrollment: 184
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy.
Experimental: Influenza Vaccine Intervention
The intervention group will receive a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions.
 Other: Influenza Vaccine Intervention
The intervention will include a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. The educational intervention will focus on: (1) Hong Kong government's recommendation regarding influenza vaccine during pregnancy, (2) potential complications associated with influenza during pregnancy and for young infants, (3) safety of influenza vaccine for mother and foetus, and (4) potential benefits of influenza vaccine for mother and infant, and (5) where and how to get the influenza vaccine in Hong Kong.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • 18 years of age or older
  • in at least the second trimester of pregnancy
  • has completed a foetal anatomic ultrasound which was normal
  • Cantonese speaking
  • Hong Kong resident
  • no serious medical or obstetrical complications
  • have not yet received the influenza vaccine in this pregnancy
  • staying in Hong Kong for at least two weeks after delivery.

Exclusion Criteria:

  • not entitled to health benefits in Hong Kong (NEP)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772901

Contacts
Contact: Marie TARRANT, PhD, MPH, RN 852-28192643 tarrantm@hku.hk
Contact: Vincci CHAN 852-28192672 chanvin@hku.hk

Locations
Hong Kong
Tsan Yuk Hospital Not yet recruiting
Hong Kong, Hong Kong
Sub-Investigator: Alice CHOI, RN RM MMedS            
Kwong Wah Hospital Not yet recruiting
Hong Kong, Hong Kong
Sub-Investigator: Chu SING, RN RM            
Sponsors and Collaborators
The University of Hong Kong
Food and Health Bureau, Hong Kong
Investigators
Principal Investigator: Marie TARRANT, PhD, MPH, RN The University of Hong Kong
  More Information

No publications provided

Responsible Party: Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01772901     History of Changes
Other Study ID Numbers: PIV-INT-1
Study First Received: January 17, 2013
Last Updated: January 18, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
influenza
influenza vaccines
infectious disease
pregnancy

Additional relevant MeSH terms:
Communicable Diseases
Infection
Influenza, Human
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013